FDA ISSUES FINAL GUIDANCE ON PRESCRIPTION DRUG APPS AND SOFTWARE

SILVER SPRING, Md., Oct. 20 -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following press release:

The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines. The guidance ends longstanding uncertainty by providing recommendations about when app content is subject to FDA submission requirements, when an app should be mentioned on a drug's official label, and what companies should submit to the agency.

"Mobile apps are playing a growing role in how patients manage their medications and health conditions," said Captain Chris Wheeler, Pharm.D., Director o...